The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.

Device Description

Not Found

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called "SteriTec Instant Readout Chemical Integrator Challenge Pack, Model No.: I.T 105". This document is an FDA clearance letter and an "Indications for Use" statement. It does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving device performance in the context of advanced AI/ML algorithms.

Specifically, the document refers to a chemical indicator and its performance requirements according to FDA Chemical Indicator Guidelines and ISO 11140-1:2005. The "performance" in this context refers to the chemical integrator changing color to indicate successful sterilization conditions, not the performance of an AI/ML algorithm.

Therefore, many of your requested points are not applicable or cannot be extracted from this document, as they relate to AI/ML device studies.

However, I can extract the following information based on the document:

Acceptance Criteria and Reported Device Performance (as a chemical integrator)

The device is a chemical integrator, and its performance is described in terms of its response to specific steam sterilization conditions. The "Indications for Use" statement outlines the critical parameters and the expected response.

Acceptance Criteria (from FDA Chemical Indicator Guidelines & ISO 11140-1:2005 performance requirements for chemical integrator test packs)	Reported Device Performance (from the document)
General Performance: Meets FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. Monitors pre-vacuum steam sterilizers. Meets emulator performance standards according to ISO 11140-1:2005.Specific Performance (Critical Parameters in hospital steam sterilizers - likely referring to minimum exposure times required to achieve "pass" indication for different thresholds, or absence of "pass" for under-exposure):	General Performance: The SteriTec Instant Readout Chemical Integrator Challenge Pack "meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." The Integrator Challenge Pack "monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F)." "When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green." "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."Specific Performance Thresholds (as described for the device): The table in the "Indications for Use" provides the "Critical Parameters" for the device, which, in the context of a chemical integrator, define the conditions under which it is expected to respond. The "Indicator "A", "B", "C"" columns likely correspond to different performance thresholds within the ISO standard or internal validation, showing the minimum exposure times at which the integrator should indicate a "pass" or "fail" for various conditions. For a chemical integrator, "performance" means accurately reflecting the conditions it is designed to monitor (e.g., changing color when sterilization conditions are met, and not changing color when they are not). The document implies the device operates according to these thresholds.132°C (270°F) / Pre-Vacuum: - Indicator "A": 4 minutes - Indicator "B": 10 minutes - Indicator "C": 20 minutes135°C (275°F) / Pre-Vacuum: - Indicator "A": 3 minutes - Indicator "B": 8 minutes - Indicator "C": 16 minutes(Note: The document doesn't explicitly state "pass/fail" results for these specific indicator times, but rather lists them as the "Critical Parameters" the device monitors and for which its performance is defined against, i.e., it must behave as expected at these time points for each indicator type.)
Temperature/Sterilizer Type:- 132°C (270°F) / Pre-Vacuum- 135°C (275°F) / Pre-Vacuum

Acceptance Criteria (from FDA Chemical Indicator Guidelines & ISO 11140-1:2005 performance requirements for chemical integrator test packs)

Reported Device Performance (from the document)

General Performance: Meets FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. Monitors pre-vacuum steam sterilizers. Meets emulator performance standards according to ISO 11140-1:2005.Specific Performance (Critical Parameters in hospital steam sterilizers - likely referring to minimum exposure times required to achieve "pass" indication for different thresholds, or absence of "pass" for under-exposure):

General Performance: The SteriTec Instant Readout Chemical Integrator Challenge Pack "meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." The Integrator Challenge Pack "monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F)." "When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green." "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."Specific Performance Thresholds (as described for the device): The table in the "Indications for Use" provides the "Critical Parameters" for the device, which, in the context of a chemical integrator, define the conditions under which it is expected to respond. The "Indicator "A", "B", "C"" columns likely correspond to different performance thresholds within the ISO standard or internal validation, showing the minimum exposure times at which the integrator should indicate a "pass" or "fail" for various conditions. For a chemical integrator, "performance" means accurately reflecting the conditions it is designed to monitor (e.g., changing color when sterilization conditions are met, and not changing color when they are not). The document implies the device operates according to these thresholds.132°C (270°F) / Pre-Vacuum: - Indicator "A": 4 minutes - Indicator "B": 10 minutes - Indicator "C": 20 minutes135°C (275°F) / Pre-Vacuum: - Indicator "A": 3 minutes - Indicator "B": 8 minutes - Indicator "C": 16 minutes(Note: The document doesn't explicitly state "pass/fail" results for these specific indicator times, but rather lists them as the "Critical Parameters" the device monitors and for which its performance is defined against, i.e., it must behave as expected at these time points for each indicator type.)

Temperature/Sterilizer Type:- 132°C (270°F) / Pre-Vacuum- 135°C (275°F) / Pre-Vacuum

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The SteriTec Instant Readout Chemical Integrator Challenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." And, "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."

This indicates that the device underwent testing to demonstrate compliance with these established standards. However, the document does not provide the details of this study, such as its methodology, results, or specific data.

Information NOT available in the provided document (as it pertains to AI/ML studies and not applicable to this chemical indicator device):

Sample size used for the test set and the data provenance: Not applicable. This refers to a physical chemical indicator, not an algorithm processing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a chemical indicator is determined by physical sterilization conditions and its visual color change.
Adjudication method: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This device doesn't involve human readers or AI assistance in a diagnostic context.
Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a chemical indicator, the ground truth is the actual physical parameters of the sterilization cycle (temperature, time, steam quality), verified by calibrated equipment. The "expert consensus" relates to the FDA and ISO standards defining what constitutes a successful sterilization cycle and thus a "pass" indication from the device.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires training data.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

Ms. Linda Nelson Regulatory Affairs Manager SteriTec Products Manufacture Company, Incorporated 599 Topeka Way Suite 400 Castle Rock, Colorado 80109

Re: K080136

Trade/Device Name: Instant Readout Chemical Integrator Challenge Pack, Model No.: I.T 105 Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator Regulatory Class: II Product Code: JOJ Dated: August 05, 2008 Received: August 12, 2008

Dear Ms. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Nelson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if annlicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Cler

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080136

Device Name: SteriTec Instant Readout Chemical Integrator Challenge Pack, Model No.: LT 105

Indications For Use:

Critical Parameters in hospital steam sterilizers

Temperature/Sterilizer Type	Indicator "A”	Indicator "B"	Indicator "C"
132°C (270°F)/Pre-Vacuum	4 minutes	10 minutes	20 minutes
135°C (275°F)/Pre-Vacuum	3 minutes	8 minutes	16 minutes

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sharla H. Murphy, MD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number:

K 080136

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).